Irwin Dobrushin, a Certified Industrial Hygienist, answered: No, loss of sight without the physical removal of the eye is not a reportable event under the requirements in Section 1904.39. However, a case involving loss of sight that results in the in-patient hospitalization of th …

Food and drug regulatory attorney Karl M. Nobert answered: Yes. A Cough / Cold OTC Drug containing such a combination can be legally marketed and sold in the U.S. without risk of FDA enforcement action, so long as it is done in compliance with FDA’s OTC drug regulations a …

John Chapman, expert in Medical Device Regulatory Affairs, answered: According to CDC’s recommendations, only critical devices need a six-log reduction (sterilization). This is similar to FDA’s Safety Alert Updated March 4, 2015 for duodenoscopes: To support high level disinf …

Robert J. Russell, a specialist in global regulatory issues for the pharmaceutical industry, answered: Yes, however each country is different in their interpretation of who they consider to be a Tier I Healthcare Authority. They will almost always want to see an approval from the …

Labor & Employment Law expert Susan Fahey Desmond answered: The FMLA applies to an employee’s “serious health condition”—regardless of the source of that serious health condition—be it on duty or off duty. A serious health condition is one that lasts more than 3 con …

HR expert Mary Gormandy White answered: You might want to consider adding in Instagram for recruiting college-age candidates; it’s a great place to share pics of your great work environment, highlight happy employees (maybe photos of employees with quotes about why the love wor …

Food Safety and Compliance Consultant Natasha Rowley-Phipps answered: If every element of the new proposed ruling is passed and put into final regulation, there will be substantial cost to manufacturers to change all of their packaging. There will be significant time to do this, …

Labor & Employment Law expert Susan Fahey Desmond answered: The FMLA requires an employer to give up to 12 weeks in a 12 month period for a serious health condition – even if it is burdensome to do so. The ADA, however, does not have a “12 week” period written into it, …

Quality Assurance consultant Dev Raheja answered: I recommend performing software validation on processes in which the desired outcome is sufficiently verified, even if those processes do include software. Validation requires objective evidence that it works correctly in actual c …

XYZ Inc has 4 separate companies, as well as an individual Services company that is not Inc but rather an LLC.Currently, we are completing an OSHA 300A for each company and then a separate OSHA 300A for all companies combined. Would that be considered double …